510(k) Report

Devices descending from K100502

126 later devices reach Ascension Total Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—